Closed loop optimization of a-v and v-v timing

ABSTRACT

Embodiments of close loop optimization of atrio-ventricular (A-V) delay interval and/or inter-ventricular (V-V) timing are disclosed. An implantable medical device includes a housing that supports a processing means adapted for implantation in a patient. There can be two or more electrodes electrically coupled to the processing means where the two or more electrodes can be used for sensing a patient&#39;s cardiac signals, which include a far-field EGM. The processing means can determine a width of a P-wave from the sensed far-field EGM. Also included can be a means for delivering an adapted cardiac pacing therapy based upon the width of the P-wave, including revised A-V delay and/or V-V temporal intervals.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/323,314, filed Dec. 30, 2005 entitled “CLOSED LOOP OPTIMIZATION OFA-V AND V-V TIMING”, herein incorporated by reference in its entirety.

BACKGROUND

Many embodiments in the present disclosure relate to implantable cardiacpulse generators (IPGs) generally, and more particularly to implantablecardioverters defibrillators (ICDs) and triple-chamber pacing devicesconfigured to deliver cardiac resynchronization therapy (CRT).

Cardiac conduction defects and various co-morbidities of heart failurecan confound the natural cardiac depolarization sequence so that upperand lower chambers fail to electrically conduct and mechanicallycontract during normal sinus rhythm (NSR) and/or without ventricularsynchrony. In certain heart failure patients, the heart may becomedilated, and the conduction and depolarization sequences of the heartchambers may, for example, exhibit inter- and/or intra-atrial conductiondefects (IACD), left bundle branch block (LBBB), right bundle branchblock (RBBB), and inter-ventricular conduction defects (IVCD) and thelike. In patients suffering from each or a combination of suchconduction defects, a lack of synchrony and/or complementary blood flowamong the chambers can diminish cardiac output and impair perfusion ofthe organs of tissues of the patient. In addition, spontaneousdepolarizations originating within the right atrium, left atrium(RA,LA), the right ventricle (RV), and/or the left ventricle (LV) canarise from diverse locations (e.g., at one or more ectopic foci) thusdisturbing the natural activation sequence. Further, significantconduction disturbances between the RA and LA can result in atrialflutter or fibrillation (e.g., which can significantly impair LV fillingdue to the arrthymia within the LA).

It has been proposed that various conduction disturbances involving bothbradycardia and tachycardia conditions could be overcome by applyingpacing pulses at multiple electrode sites positioned in or about asingle or multiple chambers of a heart in synchrony with adepolarization that is sensed at one of multiple electrode sites. It isbelieved that cardiac output can be significantly improved when left andright chamber synchrony is restored, particularly in patients sufferingfrom dilated cardiomyopathy and heart failure.

For patients with dual chamber or triple chamber implantable devicesappropriate timing between the RA and RV and the LA and LV is beneficialto achieve optimal hemodynamics. One consideration for selecting theappropriate timing is the time relationship between right and leftatrial contraction. In current implantable systems, RA contraction canbe determined from the RA electrical depolarization sensed from one ormore electrodes coupled to a lead disposed in communication with the RA.In these systems, there is no good way to determine the electricaldepolarization and mechanical contraction timing of the LA. This isbecause the bipolar RA electrogram (EGM) mostly represents the localizedelectrical activities (e.g., near field) in the RA and not the LA. Theunipolar RA EGM from the RA tip also suffers from the similar limitationas the tip signal is dominated by the local myocardium around the tipelectrode.

In current practice, clinicians have used Doppler echocardiography toguide A-V and/or V-V optimization in patients with CRT. They aretypically done a month or so after implant. Sometimes, clinicians wouldonly selectively perform so-called echo-guided optimization innon-responder patients (i.e., patients that fail to improve hemodynamicsin response to CRT delivery) due to increased number of device implantsas well as difficulties in scheduling visits to qualified clinicianssuch as an electrophysiologist or an echo technician. However, it isunknown whether the A-V delay interval or inter-ventricular (V-V)interval, if any, selected during an echo-guided optimization performedwhen the patient is supine and resting are the same as when the patientis ambulatory and active. Similarly, as the patient's disease stateevolves, for example, due to an acute heart failure decompensation eventor because of deleterious remodeling that occurs in the progression ofheart failure or otherwise during the course of heart failure treatmentand therapy, it is foreseeable that the A-V and/or V-V timing wouldchange as well and thus benefit from a closed loop method and apparatusfor adapting to same.

DRAWINGS

FIG. 1 shows an implanted device such as a pacemaker in an embodiment ofthe present invention;

FIG. 2 is a schematic diagram depicting a multi-channel, atrial andbi-ventricular, monitoring/pacing implantable medical device (IMD) inwhich embodiments of the invention are preferably implemented;

FIG. 3A is a simplified block diagram of one embodiment of IPG circuitryand associated leads employed in the system of FIG. 2 enabling therapydelivery and heart failure state monitoring in one or more heartchambers;

FIG. 4 is a simplified block diagram of a single monitoring and pacingchannel for deriving pressure, impedance and cardiac EGM (electrogram)signals employed in monitoring heart failure and optionally pacing theheart and delivering therapy in accordance with the embodiments of theinvention;

FIGS. 5A-5E are schematic illustrations of possible three electrodepositions on the case and/or lead of an implantable medical device forpracticing the concepts of the present invention;

FIG. 6 is a flowchart diagram showing detection of a P-wave in anembodiment of the present invention.

DESCRIPTION OF VARIOUS EMBODIMENTS

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the invention. Various modificationsto the illustrated embodiments will be readily apparent to those skilledin the art, and the generic principles herein may be applied to otherembodiments and applications without departing from embodiments of theinvention. Thus, embodiments of the invention are not intended to belimited to embodiments shown, but are to be accorded the widest scopeconsistent with the principles and features disclosed herein. Thefollowing detailed description is to be read with reference to thefigures, in which like elements in different figures have like referencenumerals. The figures, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope ofembodiments of the invention. Skilled artisans will recognize theexamples provided herein have many useful alternatives and fall withinthe scope of embodiments of the invention. The following introductorymaterial is intended to familiarize the reader with the general natureand some of the features of embodiments of the invention.

Referring now to FIG. 1, a diagram is shown illustrating the environmentof the apparatus and method of certain embodiments of this invention.The invention may be used with an implantable device such as a pacemaker3, illustrated as implanted within a patient. Connected to the pacemakeris a lead 2, which extends into the patient heart, and has one or moreelectrodes at the distal end thereof that deliver stimulus pulses andalso sense intracardiac or epicardial signals. As is well known in thepacemaker art, the sense signals can be received by the pacemaker,digitized and stored in memory, for later transmission to an externaldevice; alternately, they can be downloaded directly to an externalprogrammer device. Likewise, one or more sensors located on the lead orin the pacemaker can produce the signals that are to be digitized andstored. As shown, the transceiver 1 may be a conventional programmer asused in the pacemaker art. The programmer, when it has received datafrom the pacemaker, can transfer it to a processor 4, which in turn canoutput data to input/output device 5, all in a well-known manner.

FIG. 2 depicts an implanted, multi-channel cardiac pacemaker, ICD, IPG(implantable pulse generator) or other IMD of the above noted types forrestoring A-V synchronous contractions of the atrial and ventricularchambers and simultaneous or sequential pacing of the right and leftventricles. The pacemaker IPG 14 is implanted subcutaneously in apatient's body. Up to three endocardial leads 16, 32, and 52 connect theIPG 14 with the RA, the RV and the LV, respectively. Each lead includesat least one electrical conductor and pace/sense electrode, and a remoteindifferent can electrode 20 is formed as part of the outer surface ofthe housing of the IPG 14. As described further below, the pace/senseelectrodes and the remote indifferent can electrode 20 (IND_CANelectrode) can be selectively employed to provide a number of unipolarand bipolar pace/sense electrode combinations for pacing and sensingfunctions. The depicted positions in or about the right and left heartchambers are also merely exemplary. Moreover other leads and pace/senseelectrodes may be used instead of the depicted leads and pace/senseelectrodes that are adapted to be placed at electrode sites on or in orrelative to the RA, LA, RV and LV.

The depicted bipolar endocardial RA lead 16 is passed through a veininto the RA chamber of the heart 10, and the distal end of the RA lead16 is attached to the RA wall by an attachment mechanism 17. The bipolarendocardial RA lead 16 is formed with an in-line connector 13 fittinginto a bipolar bore of IPG connector block 12 that is coupled to a pairof electrically insulated conductors within lead body 15 and connectedwith distal tip RA pace/sense electrode 19 and proximal ring RApace/sense electrode 21. Delivery of atrial pace pulses and sensing ofatrial sense events is effected between the distal tip RA pace/senseelectrode 19 and proximal ring RA pace/sense electrode 21, wherein theproximal ring RA pace/sense electrode 21 functions as an indifferentelectrode (IND_RA). Alternatively, a unipolar endocardial RA lead couldbe substituted for the depicted bipolar endocardial RA lead 16 and beemployed with the IND_CAN electrode 20. Or, one of the distal tip RApace/sense electrode 19 and proximal ring RA pace/sense electrode 21 canbe employed with the IND_CAN electrode 20 for unipolar pacing and/orsensing.

Bipolar, endocardial RV lead 32 is passed through the vein and the RAchamber of the heart 10 and into the RV where its distal ring and tip RVpace/sense electrodes 38 and 40 are fixed in place in the apex by aconventional distal attachment mechanism 41. The RV lead 32 is formedwith an in-line connector 34 fitting into a bipolar bore of IPGconnector block 12 that is coupled to a pair of electrically insulatedconductors within lead body 36 and connected with distal tip RVpace/sense electrode 40 and proximal ring RV pace/sense electrode 38,wherein the proximal ring RV pace/sense electrode 38 functions as anindifferent electrode (IND_RV). Alternatively, a unipolar endocardial RVlead could be substituted for the depicted bipolar endocardial RV lead32 and be employed with the IND_CAN electrode 20. Or, one of the distaltip RV pace/sense electrode 40 and proximal ring RV pace/sense electrode38 can be employed with the IND_CAN electrode 20 for unipolar pacingand/or sensing. Also depicted in FIG. 2 is an RV sensor 55 and an LVsensor 59 which may comprise one or more of a variety of sensors as isknown in the art. Preferably RV sensor 55 comprises an absolute pressuresensor, but other pressure sensors may be utilized. In addition, RVsensor 55 may comprise an accelerometer, an impedance electrode, asaturated oxygen sensor, a pH sensor, and the like. Of course, suchsensors must be rendered biocompatible and reliable for long-term use.In addition, one or more sensors may be disposed in or on the housing 20of IMD 14 such as sensors A, B, or C depicted in FIG. 2.

FIG. 3A depicts a system architecture of an exemplary multi-chamber IMD100 implanted into a patient's body 10 that provides delivery of atherapy and/or physiologic input signal processing. The typicalmulti-chamber monitor/sensor 100 has a system architecture that isconstructed about a microcomputer-based control and timing system 102that varies in sophistication and complexity depending upon the type andfunctional features incorporated therein. The functions ofmicrocomputer-based multi-chamber monitor/sensor control and timingsystem 102 are controlled by firmware and programmed software algorithmsstored in RAM and ROM including PROM and EEPROM and are carried outusing a CPU, ALU, etc., of a typical microprocessor core architecture.Of course, such firmware and software may be modified in situ (e.g., invivo) and the operational characteristics may be adapted for aparticular situation or patient. A physician or clinician may change oneor more parameters that will cause a change in the detection or responseof such algorithms. Discrete values may be changed such that a desiredsoftware routine is advantageously altered, although sometimes anentirely new set of operating software may be substituted for anexisting set of operating software, as is known in the art. Themicrocomputer-based multi-chamber monitor/sensor control and timingsystem 102 may also include a watchdog circuit, a DMA controller, ablock mover/reader, a CRC calculator, and other specific logic circuitrycoupled together by on-chip data bus, address bus, power, clock, andcontrol signal lines in paths or trees in a manner well known in theart. It will also be understood that control and timing of multi-chambermonitor/sensor 100 can be accomplished with dedicated circuit hardwareor state machine logic rather than a programmed microcomputer.

The multi-chamber monitor/sensor 100 also typically includes patientinterface circuitry 104 for receiving signals from sensors andpace/sense electrodes located at specific sites of the patient's heartchambers and/or delivering stimulation to derive heart failureparameters or a pacing therapy to the heart chambers. The patientinterface circuitry 104 therefore comprises a stimulation deliverysystem 106 optionally including pacing and other stimulation therapiesand a physiologic input signal processing circuit 108 for processing theblood pressure and volumetric signals output by sensors. For purposes ofillustration of the possible uses of these embodiments of the invention,a set of lead connections are depicted for making electrical connectionsbetween the therapy delivery system 106 and the input signal processingcircuit 108 and sets of pace/sense electrodes located in operativerelation to the RA, LA, RV and LV.

The physiologic input signal processing circuit 108 therefore includesat least one electrical signal amplifier circuit for amplifying,processing and in some cases detecting sense events from characteristicsof the electrical sense signal or sensor output signal. The physiologicinput signal processing circuit 108 in multi-chamber monitor/sensorsproviding dual chamber or multi-site or multi-chamber monitoring and/orpacing functions includes a plurality of cardiac signal sense channelsfor sensing and processing cardiac signals from sense electrodes locatedin relation to a heart chamber. Each such channel typically includes asense amplifier circuit for detecting specific cardiac events and an EGMamplifier circuit for providing an EGM signal to the control and timingsystem 102 for sampling, digitizing and storing or transmitting in anuplink transmission. Atrial and ventricular sense amplifiers includesignal processing stages for detecting the occurrence of a P-wave,R-wave, or T-wave respectively and providing an ASENSE, VSENSE or TSENSEevent signal to the control and timing system 102. Timing and controlsystem 102 responds in accordance with its particular operating systemto deliver or modify a pacing therapy, if appropriate, or to accumulatedata for uplink telemetry transmission or to provide a Marker Channel®signal in a variety of ways known in the art. In addition, the inputsignal processing circuit 108 includes at least one physiologic sensorsignal processing channel for sensing and processing a sensor derivedsignal from a physiologic sensor located in relation to a heart chamberor elsewhere in the body.

FIG. 4 schematically illustrates one pacing, sensing, and parametermeasuring channel in relation to one heart chamber. A pair of pace/senseelectrodes 140, 142, a sensor 160, and a plurality, e.g., four,impedance measuring electrodes 170, 172, 174, 176 are located inoperative relation to the heart chamber. The pair of pace/senseelectrodes 140, 142 are located in operative relation to the heartchamber and coupled through lead conductors 144 and 146, respectively,to the inputs of a sense amplifier 148 located within the input signalprocessing circuit 108. The sense amplifier 148 is selectively enabledby the presence of a sense enable signal that is provided by control andtiming system 102. The sense amplifier 148 is enabled during prescribedtimes when pacing is either enabled or not enabled as described below inreference to the measurement of the parameters of heart failure. Theblanking signal is provided by control and timing system 102 upondelivery of a pacing pulse or pulse train to disconnect the senseamplifier inputs from the lead conductors 144 and 146 for a shortblanking period in a manner well known in the art. When sense amplifier148 is enabled and is not blanked, it senses the electrical signals ofthe heart, referred to as the EGM, in the heart chamber. The senseamplifier provides a sense event signal signifying the contraction ofthe heart chamber commencing a heart cycle based upon characteristics ofthe EGM, typically the P-wave when the heart chamber is the RA or LA andthe R-wave, when the heart chamber is the RV or LV, in a manner wellknown in the pacing art. The control and timing system responds tonon-refractory sense events by restarting an escape interval (El) timertiming out the El for the heart chamber, in a manner well known in thepacing art.

The pair of pace/sense electrodes 140, 142 are also coupled through leadconductors 144 and 146, respectively, to the output of a pulse generator150. The pulse generator 150, within pacing delivery system 106,selectively provides a pacing pulse to electrodes 140, 142 in responseto a PACE trigger signal generated at the timing system 102 in a mannerwell known in the pacing art.

The sensor 160 and/or other physiologic sensor is coupled to a sensorpower supply and signal processor 162 within the input signal processingcircuit 108 through a set of lead conductors 164 that convey power tothe sensor 160 to the sensor power supply and signal processor 162. Thesensor power supply and signal processor 162 samples the blood pressureimpinging upon a transducer surface of the sensor 160 located within theheart chamber when enabled by a sense enable signal from the control andtiming system 102. As an example, absolute pressure P, developedpressure DP and pressure rate of change dP/dt sample values can bedeveloped by sensor power supply and signal processor unit 162 or by thecontrol and timing system 102 for storage and processing as describedfurther below. The sensor 160 and a sensor power supply and signalprocessor 162 may take the form disclosed in commonly assigned U.S. Pat.No. 5,564,434.

Many embodiments of the present invention are geared towards detectingthe width of the P-wave. A helpful aspect of this method is to know theelectrical activation of both RA and LA. This allows the stimulation ofthe right and left ventricle at the appropriate time to allow the fullRA and LA contribution of ventricular filling and therefore optimize thehemodynamics of ventricular contraction. This is accomplished by usingthe far field (not near field) atrial electrograms (EGMs) recorded fromthe implantable CRT device. This far field EGM provides the P-wavesimilar to the surface ECG that has electrical activation from bothright and left atria. The intrinsic RA and LA activation is differentfrom the paced RA and LA activation. This method also provides thedifferent A-V and V-V timings for paced or sensed P-waves. The use ofnear field P-wave sensing may potentially be limited in providing P-wavewidth for the paced P-wave, as the electrode pair for sensing P-wavewidth is shared with pacing electrode. With the high pacing energy onthe electrodes, sensing P-wave becomes very difficult.

Detecting the P-wave width is helpful in diagnosing heart failurepatients. If a patient starts to show a widening of the P-wave, thenthis could be a precursor of heart failure and treatments could beimplemented either dynamically or through optimization by a physicianprogramming an implantable device based upon information relayed to thephysician from IPG 14. A widening of the P-wave shows a longer delaybetween the RA and LA contraction. This can be due to more fluid in theRA and LA and this indicates a worsening of heart failure or the onsetof atrial fibrillation (AF). With more fluid build up a stretching ofthe atrium occurs.

Several embodiments of the present invention include methods that use“far-field” P-waves, similar to surface electrocardiographs (ECG), todetermine the electrical activation time of the RA and LA. This could beperformed with leadless ECG and EGMs measured from button-typeelectrodes on the housing of the implantable device. The leadless ECGcan, for example, constitute a derived EGM recorded from a buttonelectrode on the housing of the implantable device to a high energycoil-type electrode disposed within a portion of the superior vena cava(SVC). By measuring ambulatory P-wave width, the device can adjust A-Vand/or V-V timing to optimize hemodynamics during pacing therapydelivery. The measurement of the P-wave width can be based on a sensedatrial event (A-event) from the bipolar RA EGM. Once a P-wave is sensed,a window around the sensed A-event can be used to detect the P-wave fromthe far-field EGM. The width can be calculated by first band passfiltering the signal to remove baseline wandering and any noise anddetermining the P-wave width with an algorithm, such as that used fordetermining R-wave width in the ICD devices. The present embodiment canbe utilized to measure LA electrical activation timing for the purposeof automatically determining an appropriate A-V and/or V-V timing inambulatory patients with implantable bi-ventricular or CRT devices.

The importance of knowing the width of the signal lies in the fact thatit is undesirable to have the LV contract while the LA is stillcontracting. Synchronous cardiac activity requires complete andcomplementary contraction of the atrium and the ventricles. Thus, theatrial contribution (including the so-called “atrial kick”) to thefilling of the LV is maximized. With increased pre-load, the LVcontraction is also increased. Therefore, it is desirable to understand,dynamically or on a real-time basis, the relative timing of the RA and,especially the LA. An accurately measured P-wave will provide the widthof the RA-to-LA (or vice versa) electrical activation time (herein the“A-A” interval) and once the width (i.e., the duration) is known then anoptimized A-V delay can be determined based on that information.

In certain embodiments, the P-wave width is measured either at certaintimes of the day, and, in other embodiments, the P-wave width ismeasured on a beat-by-beat basis. This could reduce or eliminate theneed for echo-guided A-V and V-V timing optimization at implant orfollow-up and provide an on-going optimization in ambulatory patients.Using a far-field EGM is believed to be better than using a near-fieldEGM in measuring P-wave width, since the far-field EGM approximates asurface ECG measurement.

Certain embodiments of the present invention use an electrode array toobtain a far-field EGM (e.g., a so-called subcutaneous ECG). In theseembodiments, an array of electrodes situated on or in proximity to animplanted medical device spaced from a patient's heart couples to logicmeans and interconnecting circuitry. The logic means (such as amicroprocessor) and interconnecting circuitry can selectively detectsignals representative of the far-field EGM across selected combinationsof the electrodes and the process such signals to record the EGMs instorage for subsequent read-out via telemetry or via a programmingdevice. The logic means can also develop control signals for controllingor modifying the operation of the medical device in accordance withspecific attributes of the processed far-field EGM signal.

Although the expression “far-field” is normally employed for sensingfrom one chamber (or from an electrode not disposed within a chamber) toanother chamber of the heart and another electrode (e.g., sensing aP-wave from an ventricular electrode or electrode-pair; sensing anR-wave from an atrial chamber), for purposes of this disclosure, theexpression relates not only to this common definition of “far-field”,but also to and EGM detected utilizing relatively closely spacedelectrodes in the electrode arrays discussed below, wherein the arrayitself is spaced from the heart. Due to the positioning of the array,the signals may also be referred to as “subcutaneous ECG” signals.

Examples of possible electrode orientations and configurations of athree electrode system comprising electrodes A, B and C are set forth inFIGS. 5A to 5E. In all such systems, it will be understood that theelectrodes A, B, C are electrically isolated from one another and theconductive surface of the pulse generator housing 10 through suitableinsulating bands and electrical feedthroughs as described in theaforementioned Lindemans U.S. Pat. No. 4,310,000, incorporated herein byreference in relevant part.

FIG. 5A illustrates the orientation of orthogonally disposed electrodesA, B and C with two electrodes on connector block 12 and one electrodeon IPG 14. The spacing of the electrodes A, B and C on each of theillustrated orientations of FIGS. 5A to 5E is on the order of about oneinch but can be larger or smaller depending on the exact size of thedevice. Smaller devices and closer spacing will require greateramplification.

The size of implantable pulse generators, particularly single chambercardiac pacemakers, is growing progressively smaller. FIGS. 5B and 5Cillustrate locations of at least one of the electrodes extended awayfrom the pulse generator by a stubby lead extension in FIG. 5B and asegment of the lead itself in FIG. 5C in order to achieve a greaterinter-electrode spacing, if desirable.

As illustrated in FIGS. 5C and 5D, the relative orientation of theelectrodes may vary somewhat from the orthogonal orientation depicted inFIGS. 5A and 5B. Although orthogonal electrode orientations are oftenpreferred, it will be understood that other angular orientations willsuffice and perhaps even be preferred depending on the number ofelectrodes employed and the signal processing capability of theimplanted device.

FIG. 5D depicts the electrodes A, B and C along the sides of the pulsegenerator 10. It will be understood that the electrodes placed on theedge of the pulse generator case depicted in FIG. 5D could constituteinsulated pins of feedthroughs extending through the wall of the case.

Turning again to FIG. 2, an implanted medical device is depicted inorder to show the orientation of the array of electrodes A, B, and C inrelation to housing 11. An array of three electrodes A, B, and Cdisposed orthogonally on the surface of IPG 14 and connector block 12and facing outwardly towards the patient's skin is employed to developthe far-field EGM signal comprising the PQRST signals generated in thesequential depolarization of the atrium and ventricle of the patient'sheart.

The far-field EGM reflecting the amplitude and rate of change of thePQRST complex may be sensed throughout the body as an electric fieldemanating from the electrical depolarization and subsequentrepolarization of the heart muscle. As the cardiac muscle depolarizes,the direction of the depolarizing wave front changes. The atriainitially depolarize and then the ventricles depolarize down theintraventricular septum to the apex of the heart where the direction ofthe depolarization changes as the wave front travels back up through theventricular muscle mass. Consequently, the far-field EGM sensed acrossthe three electrodes A, B, C disposed on the housing will be observed tochange both in amplitude and polarity (depending on the orientation ofthe measuring pair of electrodes in relation to the electric fieldorientation of the depolarization wave front).

The electrodes A, B and C are fixed in position unless the pulsegenerator is either moved by the patient or becomes loose in the pocket.In any case, for most applications, it is desirable to optimize thesensing of the peak amplitude of the R-wave for applications relating tosimple rate calculation, capture detection or the like by selecting theelectrode orientation that provides the highest amplitude R-wave outputsignal. For other applications, where it is desirable to obtain faithfulreproduction of both the amplitude and slew rate of sampled points ofthe PQRST complex, more elaborate signal processing schemes aredescribed.

Detection of a far-field EGM signal using the RA lead is difficult sincethe RA lead is highly localized to the right atrium (esp. if either abi-polar tip-to-ring or a unipolar tip-to-can electrode arrangement isutilized). Thus the RA signal dominates when events are detected usingsuch electrodes coupled to an RA lead thereby essentially precluding theability to accurately pick up LA contraction signals. Embodimentsdisclosed herein overcome this obstacle by using a far-field EGM orpseudo ECG to accurately measure the P-waves. Using a pseudo ECG whichis the signal at either buttons A, B, or C or from a leadless ECG whichincorporates the use of the can, as discussed above, as an alternate tohaving direct atrial tissue attachment. Thus the signal is seen fromafar. Therefore the RA and LA activation is seen and this is verysimilar to the surface ECG that would represent the RA-LA delay (or lesscommonly an LA-RA delay). It is of note, that the far field signal isnot actually sensing only the LA, but instead is sensing the entireatrial contraction and the timing between the RA and LA electricalconduction (which precedes actual mechanical contraction) is representedby the duration, or width, of the signal. Accordingly, if there is along A-A delay the P-wave width will be wider, and, if there is a shortA-A delay, the P-wave will be narrower.

Obtaining a pseudo ECG or far-field EGM from the housing or canister(sometimes referred to as “can”) 11 to SVC electrode 70 or from buttonelectrodes A, B, or C allows IPG 14 to know the width of the RA and LAcontraction and essentially the RA to LA delay. The wider the width ofthe P-wave the longer the delay. Therefore once the P-wave width isknown, the A-V timing can be better optimized, either dynamically withIPG 14 or through medication changes possibly with an implantable drugdelivery device. This provides increased optimization or on-the-fly kindoptimization of A-V timing, which has been shown to improvehemodynamics.

With reference to FIG. 6, a flowchart diagram showing detection of aP-wave width in an embodiment of the present invention is shown. Atstate 600, microprocessor 102 begins the program. At state 602,microprocessor 102 makes a determination as to whether the time is rightto take a P-wave sample. This determination can be based on a variety ofvariables, such as time of day, activity of the patient, patientposition, initiation by patient or physician, either independently or incombination with each variable.

Further, the P-wave measurement does not need to be made constantly. Forinstance, measurements would be taken at times when the patient is mostlikely to be asleep. IPG 14 can make this determination using itsinternal clock. In certain embodiments, the method calls for the use ofan activity sensor to know when the patient is stationary and thustaking measurements at that time. Some embodiments include a sensor thatdetects when the patient is in the supine position. Some embodimentsinclude a patient trigger that allows the patient, clinician orphysician to initiate P-wave monitoring if the patient should beginfeeling symptomatic. Thus the present invention can reduce certaininconsistencies to better increase the chances of receiving a very clearsignal. It may also be desirable to take measurements during both senseand pace events since a true delay may be different during a sense eventversus a paced event. This method would provide a close-loop system forA-V and V-V optimization in an ambulatory patient. There is minimalrequirement of clinician interaction to set the A-V optimization.Therefore, the A-V timing can be adjusted based on the patient activity,posture, day or night, and changes of heart failure conditions.Therefore the CRT therapy would be optimized at an on-going basis,rather at a point in time after implant.

Referring again to FIG. 6, if microprocessor 102 determines that thetime is not good to take a P-wave sample, then the routine returns tostate 602. If microprocessor 102 determines that the time is good totake a P-wave sample, then the routine proceeds to state 604 wheremicroprocessor 102 waits for the triggering event. The triggering eventcan be the RA sense, however, the triggering event can be most anythingsuch as detection of atrial pressure or atrial accelerometer signalswithout departing from the spirit of the invention. At state 604,microprocessor 102 determines whether the triggering event has occurred.If not, the routine returns to state 604 until the event occurs. If thetriggering event occurs, microprocessor 102 then takes a measurement ofthe P-wave at state 606.

As discussed above, there are challenges in being able to sense the leftatrium contraction. It would be desirable to more accurately measure thecontraction of the left atrium that could be helpful in adjusting thetiming between the left atrium and the left ventricle. Using the RAsense as a trigger in state 604 opens a window for far field detectionof the contraction of the left atrium in state 606. This triggeringevent allows IPG 14 to determine the width of the P-wave. This allowsIPG 14 to perform some functions that normally would be performed in alab, such as optimizing A-V and V-V timing dynamically or in real time.When the P-wave signal is received, in certain embodiments it is runthrough a band pass filter to reduce the amount of noise on the signal.A good band pass range would be a high-end cutoff at 60 Hz and a low-endcutoff of 30 Hz. The band pass filter also assists in improving thesignal to noise ratio.

If obtaining an average P-wave width over several measurements isdesired, the routine returns to state 602 to additional P-wavemeasurements. The P-wave measurement (or multiple measurements) isstored in memory in state 608.

At state 610, microprocessor analyzes all the P-wave information it hasaccumulated and determines if the P-wave has been widening anddetermines an average time for electrical activation to propogatebetween the RA and LA. The P-wave determination can be achieved usingalgorithms similar to the R-wave width algorithm already implemented inMedtronic single chamber ICDs, or just classic signal processingalgorithms such as an “edge” detection algorithm. From this information,microprocessor 102 then makes a determination as to whether cardiactherapy is needed. If not, the routine returns to state 602 and beginsthe process all over again. If it is determined that a therapy isneeded, then the routine proceeds to state 612 where a therapy isadministered. This therapy could be an adjustment of the A-V timing sothat the time difference between RA and LA is closely related to thetime difference between RV and LV. This will assist in increasing thehearts hemodynamics by assuring that the LA has fully contracted beforethe LV begins contraction. However, it is contemplated that othertherapies could be used such as drug delivery from an implantable drugpump without departing from the spirit of the invention. Once thetherapy has been administered and set, the program returns to state 602to begin the process all over again.

To improve the heart's hemodynamics and prevent AF, the presentinvention suggests using the P-wave width information to dynamicallychange the A-V delay, either a paced A-V (PAV) or sensed A-V (SAV)delay. IPG 14 could pace the ventricle after the contraction of the leftatrium. Thus, the longer the A-A delay a relatively lengthened A-V delaycan be programmed or implemented to help restore complementary atrialfilling and ventricular ejection of blood (i.e., hemodynamics). Thisway, the CRT timing can be adjusted automatically based on the changesof P-wave width, as a reflection of the timing of LA contraction. Thereverse could also be used. For example, if the patient gets better asreflected in a reduced A-A interval, a therapeutic change of timing forthe patient would include shortening the A-V delay to avoid pacing theLV “too late” in the cardiac cycle. Likewise, in the case of CRTdelivery an operating V-V interval can be changed to compensate foroffset A-A conduction or changing A-A conduction intervals so thatventricular synchrony is maintained or restored.

Once the P-wave width is determined, electrical activation timing of theLA can be determined and the RA electrical activation can be found fromthe near field P-wave or A sense. At this time, the LA to LV delay canbe determined in several ways. 1) from basic physiology, we know thetime from electrical activation of atrium to mechanical contraction ofthe atrium (in the range of 40-60 ms), which is expected to berelatively stable in patients. First, the time from electricalactivation of atrium to mechanical contraction of the atrium is knownfrom basic physiology to be in the range of 40-60 ms. This amount isexpected to be relatively stable in patients. The A-V timing (in thiscase RA timing to LV timing) can be determined to be, for instance, theP-wave width plus 60 ms. In addition, for more precise determination,Echo can be used to determine the time of LA electrical activation toatrial contraction (i.e., blood flow into ventricle). This only has tobe done once and the number can be entered into the programmer for thedevice. The RA to RV timing may be determined in a similar way.Therefore the optimized A-V and V-V timing may be achieved.

Thus, embodiments of the CLOSE LOOP OPTIMIZATION OF A-V AND V-V TIMINGare disclosed. One skilled in the art will appreciate that the presentinvention can be practiced with embodiments other than those disclosed.The disclosed embodiments are presented for purposes of illustration andnot limitation, and the present invention is limited only by the claimsthat follow.

1. An implantable medical device, comprising: a housing includingprocessing means adapted for implantation in a patient; two or moreelectrodes electrically coupled to the processing means, the two or moreelectrodes for sensing patient cardiac signals including a far-fieldEGM, the processing means for determining a width of a P-wave from thesensed far-field EGM; and a means for delivering a cardiac therapy basedupon the width of the P-wave.
 2. A device according to claim 1, whereinthe two or more electrodes include an electrode operatively coupled to aportion of the housing.
 3. A device according to claim 1, wherein thetwo or more electrodes include an electrode on an implantable lead.
 4. Adevice according to claim 3, wherein the electrode on the implantablelead comprises an electrode coupled to a high voltage defibrillationelectrode.
 5. A device according to claim 1, wherein the two or moreelectrodes include an electrode array.
 6. A device according to claim 5,wherein the array of electrodes are disposed orthogonally relative toeach other.
 7. A device according to claim 1, wherein the two or moreelectrodes do not contact an atrium of the patient.
 8. Acomputer-readable medium programmed with instructions for detectingcardiac signals in an implantable medical device, the medium comprisinginstructions for causing a programmable processor to: obtaining afar-field EGM signal using sensors of the implantable medical device;determining a P-wave width from the far-field EGM signal; and deliveringa cardiac therapy based on the determined P-wave width.
 9. A mediumaccording to claim 8, wherein the cardiac therapy delivery includeschanging an A-V delay interval setting.
 10. A medium according to claim8, wherein the cardiac therapy delivery includes changing a V-V intervalsetting.
 11. A medium according to claim 8, further includinginstructions to determine whether detection by the medical device of asample cardiac P-wave is desirable.
 12. A medium according to claim 8,wherein determining whether detection of the sample cardiac P-wave isdesirable is based on at least one of: a time of the day, a posture of apatient, an activity of the patient, an activation by the patient.
 13. Amedium according to claim 8, further including instructions to determinewhether a triggering event occurred.
 14. A medium according to claim 13,wherein the triggering event comprises a sensed right atrialcontraction.
 15. A medium according to claim 13, further includinginstructions to obtain the far-field EGM signal when a triggering eventhas occurred.
 16. A medium according to claim 8, wherein the cardiactherapy is applied to a left ventricle based on a time differencebetween a right atrial event and a left atrial event.
 17. An implantablemedical device, comprising: a housing supporting processing meansadapted for implantation in a patient; two or more electrodeselectrically coupled to the processing means, the two or more electrodesfor sensing patient cardiac signals including a far-field EGM withoutcontacting an atria of the patient, the processing means adapted todetermine a width of a P-wave from the sensed far-field EGM; and a meansfor adjusting a therapy timing provided by the device based on thedetermined width of the P-wave.
 18. A system according to claim 17,further including a memory for storing multiple P-wave measurements. 19.A system according to claim 17, wherein the therapy timing is adjustedbased on the multiple P-wave measurements.
 20. A system according toclaim 17, wherein the housing supports the two or more electrodes.